Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07045701 | FMXIN002 in Patients at Risk of Anaphylaxis | PHASE2 | ENROLLING BY_INVITATION | 30 | — | — | Jun 12, 2025 | Jul 12, 2026 | Jul 1, 2025 | 1 | Israel |
Severity grading system for acute allergic reactions. Skin system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, mucosal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021
Severity grading system for acute allergic reactions, gastrointestinal system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, respiratory system, severity score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Severity grading system for acute allergic reactions, Combined systems, anaphylaxis score 0 (=no reaction) to 5(= severe reaction), based on the Delphi study, 2021.
Systolic and diastolic blood pressure by a blood pressure cuff
heart rate by pulse rate measurement
% oxygen saturation measurement using oxygen monitor
| Arm | Type | Description |
|---|---|---|
| FMXIN002 4mg + saline IM | EXPERIMENTAL | Epinephrine powder nasal spray together with a placebo IM injection |
| Adrenaline 0.5mg IM + placebo nasal spray | ACTIVE_COMPARATOR | Epinephrine IM injection together with a placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| Epinephrine 4mg nasal powder spray | COMBINATION_PRODUCT | Epinephrine nasal powder spray in a unidose nasal applicator device. Will be administered together with a placebo saline IM injection |
| Adrenalin 0.5mg Injectable Product | COMBINATION_PRODUCT | Epinephrine 0.5mg for IM injection. Will be administered together with a placebo nasal powder spray. |
Inclusion Criteria: * Age 18-40 years, any gender * Documented or suspected food allergy (based on IgE level or clinical history) * Development of Grade II or III reaction during OFC Exclusion Criteria: * Age \<18 or \>40 * Poorly controlled asthma (FEV1 \< 80% or frequent symptoms) * Active eosi...